Senior Quality Assurance Specialist
2 weeks ago
Company: bioMerieux, Inc.
Location: Salt Lake City, UT
Job Type: Unfixed Term
Department: Quality Assurance
bioMerieux, a leader in the in vitro diagnostics sector for over 60 years, is dedicated to providing diagnostic solutions that identify the origins of diseases and contamination, thereby enhancing patient health and ensuring consumer safety.
With a robust workforce of over 6,200 employees across multiple sites in North America, including BioFire Diagnostics in Salt Lake City, we invite you to join our family-oriented global organization that values long-term vision and a human-centered culture.
Role Overview:
As a Senior Quality Assurance Specialist, you will be an integral part of our Reagents Quality Assurance Team. This position operates on a C Shift schedule, consisting of 12-hour shifts from Sunday to Tuesday, with alternating Wednesdays (6:00 PM - 6:30 AM).
Key Responsibilities:
- Adhere to company policies and the established Quality System in all tasks.
- Review, evaluate, and monitor processes and products to ensure adherence to quality standards.
- Contribute to various Quality Assurance subunits as needed.
- Conduct thorough inspections of products, including labels, to ensure compliance with specifications and procedures.
- Identify and escalate any non-conformances detected during inspections, collaborating with production teams to address issues.
- Maintain accurate documentation practices during the review of quality documents and records, reporting any discrepancies to the appropriate systems.
- Authorize the release of work in process for finished goods processing.
- Organize and archive quality records in accordance with established protocols.
- Prioritize product releases to align with departmental objectives.
- Report any observed floor failures during routine inspections of manufacturing areas.
- Review and approve Device History Records.
- Manage the receipt and holding of finished goods inventory until release is authorized.
- Facilitate the release of finished goods into stock inventory.
- Coordinate the validation inventory for molded parts.
- Ensure that manufacturing equipment meets the necessary requirements for validation.
Join us in our mission to improve health outcomes through quality assurance and innovative diagnostic solutions.
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